The Effects of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers

Not Applicable

Completed

• Conditions: Military Training

• Registration Number: NCT02762968
• Lead Sponsor: Metabolic Technologies Inc.

Brief Summary

The study will determine whether acute ingestion of a probiotic combined with beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers during 8-weeks of advanced infantry training.

Detailed Description

Up to sixty soldiers from an elite infantry unit will perform a parallel design investigation. Soldiers will be randomly assigned to one of four groups. Group 1 will consume the probiotic plus HMB, group 2 will consume HMB only, group 3 will consume only the probiotic, and group 4 will consume only placebo. All four groups will be garrisoned together, eat the same meals, and perform the same activity. All groups will be tested before as well as after an 8-week advanced infantry training program. During each testing session resting blood samples will be obtained to assess cytokine, inflammatory, and muscle damage markers. Additionally, questionnaires will be used to determine digestive health. Anthropometric, performance, and muscle volume measures will also be assessed prior to and immediately following the supplementation and training protocol.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 18 years of age
• Member of the same unit of the IDF

Exclusion Criteria

• Current use of dietary supplements
• Current chronic use of medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maintenance of Immune function	8 weeks	Immune function assessed by blood biochemical analysis (ELISA).

Secondary Outcome Measures

Name	Time	Method
Maintenance of Digestive Function	8 Weeks	Digestive function assessed by questionnaire.
Maintenance of Muscle Volume	8 Weeks	Muscle volume will be assessed using a 3.0 Tesla whole-body imager (cubic centimeter)

Trial Locations

Locations (1)

Israel; 🇮🇱 Beersheva, Israel